3-chloropropene

Endpoint summary

Description of key information

- skin irritation:             irritating  for the rabbit skin; weight of evidence approach 
- eye irritation:               slightly irritating for the mouse eye; weight of evidence approach 
- respiratory irritation: irritating for the respiratory system; weight of evidence approach 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

- skin irritation: The classification of the key parameter is based on a weight of evidence approach. One up-to-date study (BASF 1990A, reliability Klimisch 3 due to lack of information on purity, using 0.5 g of substance, according to OECD TG 404) is available that reports as only effect a slight reddening of the treated skin that persisted for 24 h and was fully reversible within 48 h. No edema were reported. Unfortunately substance purity is not reported. Smyth 1948 determined the skin irritation potential of 3 -chloropropene to be equal to acetone after application of 10 µL to clipped albino rabbit skin. This result is nevertheless questionable, as the purity of the substance is not given and is probably of technical grade as at 1948. The same restriction applies for human exposure related data from NIOSH (1976) and Torkelson & Rowe (1981) that describe dermatitis and blistering including damage to the subcutaneous tissues and deep-seated pain (described as bone-ache type) beneath the point of skin contact after the contact to very small amounts of 3-chloropropene (exact quantity not given, report as citation from an unpublished report of the Shell Chemical Company on 3-chloropropene). To these facts the BUA report 186 adds in its summary the observations that 1 out of 10 animals in the inhalation experiment at 800 ppm showed focal ulcerative dermatitis. But this finding is singular and no comparable lesion was seen at higher or lower concentration and should therefore be disregarded. In addition BUA cites skin damage on tails of mice after being immersed into a 3 -chloropropene solution for 3 - 5 hours. But as these conditions are harsh and not comparable to a normal skin irritation experiment this findings should be disregarded as well. In summary based on the only up-to-date study 3 -chloropropene should be deemed not irritating to the skin. But the purity of the substance in this test remains unclear. Contradicting information on animal data and human exposure data is even less reliable, though reporting irritative potency of 3 -chloropropene.

Following a conservative approach 3 -chloropropene is deemed a skin irritant which is in-line with the current classification and labelling.

- eye irritation: The classification of the key parameter is based on a weight of evidence approach. Only one up-to-date study (BASF 1990B, reliability Klimisch 3 due to lack of substance purity information, using 0.0447 g of substance). The only effect noted was a slight to moderate reddening of the conjunctiva 1 h after the treatment in both animals that was fully reversible within 24 h. No other effects were reported. The applied amount is only 44,7 % of the amount stated in the guideline. As the effects reported are minimal and reversible within 24 h it can reasonably be assumed that even at a dose of 0.1 mL effects that would trigger a classification would not be seen. Nielsen (1985) showed that irritation of respiratory tract and eyes is due to sensory irritation rather then tissue irritation or damage. In contrary to this data NIOSH 1976 and Torkelson and Rowe (1981) report based on human exposure data for eye irritation the following symptoms in workers after exposure to 3 -chloropropene vapors: irritation of the conjunctivae and eyelids and orbital pain, which generally occurred 2 -6 hours after exposure, which was relieved somewhat by limiting the patient's exposure to bright lights. Carpenter (1946) states moderate eye irritation after instillation of 0.5 mL 3 -chloropropene of unknown purity (probably production grade as at 1946) to the rabbit eye.

As with skin irritation the lack of substance purity information renders a conclusive interpretation of the contradicting data difficult.

Following a conservative approach 3 -chloropropene is deemed an eye irritant which is in-line with the current classification and labelling.

- respiratory irritation: Nielsen (1985) showed that the respiratory depression after 3 -chloropropene in mice is due to sensory irritation rather then tissue irritation or damage (Alarie test with normal and tracheal cannulated mice, RD50(0 - 10 min exposure) = 2330 ppm (1980 - 2730 = 95 % CL)).

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

- skin irritation: Based on the above stated weight of evidence approach the test item is deemed irritating to the skin Category 2 (Warning, H315: Causes skin irritation) according to CLP as implementation of UN GHS in the EU (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL).

- eye irritation: Based on the above stated weight of evidence approach the test item is deemed irritating to the eye Category 2 (Warning, H315: H319: Causes serious eye irritation) according to CLP as implementation of UN GHS in the EU (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL).

- respiratory irritation: No regulation for classification for respiratory irritation is available from OECD GHS. Based on the above stated results from Nielsen (1985) the respiratory depression after 3 -chloropropene in mice is due to sensory irritation rather then tissue irritation or damage. Therefore a classification for respiratory irritation according to CLP as implementation of UN GHS in the EU (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) is not necessary.